FDA Medical devices recall ·
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid… recall
- Recall number
- Z-0678-2025
- Date
- (initiated October 31, 2024)
- Company / brand
- Hermes Medical Solutions AB
Strandbergsgatan 16, Stockholm, Sweden - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 778 systems
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
Why was it recalled?
Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Hermes Medical Imaging System version 6.1 with Hybrid Recon version 4.0.x UDI-DI code: 00859873006158 Serial Numbers: Pending Hybrid Recon version 5.0.0 UDI code: (01)00859873006196(8012)005000000 Serial Numbers: Pending
Distribution
U.S.: CA, CT, FL, HI, KY, MA, MD, MO, NJ. NY, OH, TN, TX, VA, and WA O.U.S.: Germany, and United Kingdoms
States: California Connecticut Florida Hawaii Kentucky Massachusetts Maryland Missouri New Jersey New York Ohio Tennessee Texas Virginia Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0678-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.